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Process Development Associate II
San Diego, CA
12+ Month Contract
3rd Shift 9 PM-07:30 Wednesday-Saturday
Under minimal supervision design and carry out fermentation /recovery experiments, recording data, maintenance/housekeeping and troubleshooting.
1. Carry out fermentation/recovery experiments
• Read SOP s (if not clear, discuss with a senior PDA/scientist). Update SOP based on discussion.
• Prep various types of media: Add chemicals, Adjust to correct volume according to SOP.
• Sterilize medium/solutions using autoclave.
• Aseptically inoculate seed flasks and place into incubator shaker according to SOP.
• Prepare fermentors /recovery equipment for SIP or CIP sequences.
• Calibrate probes according to SOPs.
• Set up fermentation/recovery parameters according to SOP using HMI or Delta V interface.
• Set up fermentors/recovery equipment-hook up all external feed bottles, adjust pH and bias, add necessary ingredients according to SOP.
• Check the inoculum for contamination using microscopy and plating.
• Inoculate ferment\ors - transfer seed into inoculation bottle and add to tank aseptically, start fermentation process.
• Sample fermentors/recovery processes and perform analysis according to SOPs.
• Prepare samples for analysis performed by external groups.
• Adjust parameters according to SOP.
• Perform aseptic techniques including operations utilizing a laminar flow hood.
• Ensure identified problems are communicated to Shift Supervisor
• Under direction of a scientist design and carry out experiments, schedule analytical support, assist in data analysis, and present results. (PDA II)
• Communicate recommendations to scientist on process improvements and SOP changes. (PAD II)
2. Authoring and revising procedural SOPs (PDA II)
• Author needed procedural SOPs to facilitate training and to ensure process standardization.
• Revise existing procedural SOPs to reflect current practices.
3. Recording data
• Complete all SOPS per GMP.
• Document any process changes or deviations.
• Document fermentation data.
• Gather all documents and print out trends. (if requested).
• Submit detailed shift reports.(if required).
• Initial the pass down log for work completed.
• Communicate maintenance issues.
4. Pilot plant housekeeping
• Ensure pilot plant and equipment is kept clean.
• Perform routine microbiological monitoring (swabs, plating).
• Assist in checking chemical/supply inventory and notifying when items are needed.
• Enter received chemicals in Chemical Inventory.
• Inform supervisor of maintenance issues and submit facilities requests for needed repairs.
• Assist with scientific troubleshooting (organism problems, feeding, etc. using trend data to identify possible solutions).
• Perform scientific troubleshooting (organism problems, feeding, etc. using trend data to identify possible solutions). (PDA II)
• Assist YSI repairs/maintenance including calibrations and membrane changes. (PDA II)
• Troubleshoot mechanical or software issues. (PDA II)
6. Assist in training new PDAs.
7. Other duties as assigned by Team Leader
Minimum Education & Experience for PDA II
BS/BA in life sciences and 3+ years of fermentation and/or microbial downstream processing experience. Or equivalent level of experience and education.
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.